CN101466421A - Fluid purge in a medical injection system - Google Patents

Fluid purge in a medical injection system Download PDF

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Publication number
CN101466421A
CN101466421A CNA200780021991XA CN200780021991A CN101466421A CN 101466421 A CN101466421 A CN 101466421A CN A200780021991X A CNA200780021991X A CN A200780021991XA CN 200780021991 A CN200780021991 A CN 200780021991A CN 101466421 A CN101466421 A CN 101466421A
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CN
China
Prior art keywords
valve
syringe
fluid
pressure
pumping installations
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Granted
Application number
CNA200780021991XA
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Chinese (zh)
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CN101466421B (en
Inventor
M·G·希伯
K·毛希丁
S·D·尼斯特罗姆
R·F·威尔逊
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ACIST Medical Systems Inc
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ACIST Medical Systems Inc
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Publication of CN101466421A publication Critical patent/CN101466421A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • A61M5/16827Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165Filtering accessories, e.g. blood filters, filters for infusion liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401Functional features
    • A61M2005/1403Flushing or purging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/0318Processes
    • Y10T137/0402Cleaning, repairing, or assembling
    • Y10T137/0419Fluid cleaning or flushing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/7722Line condition change responsive valves
    • Y10T137/7837Direct response valves [i.e., check valve type]
    • Y10T137/7879Resilient material valve
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/7722Line condition change responsive valves
    • Y10T137/7837Direct response valves [i.e., check valve type]
    • Y10T137/7879Resilient material valve
    • Y10T137/788Having expansible port

Abstract

One embodiment of the invention provides a method to purge air or liquid from a powered injection system. In this embodiment, the method includes driving a first pumping device in a first operational mode to inject an amount of a first liquid medium through disposable tubing and a disposable valve, driving the first pumping device in a second operational mode to deform the disposable valve, and driving a second pumping device to inject an amount of a second liquid medium through the disposable tubing and the deformed valve. In one embodiment, the first pumping device comprises a first syringe, the second pumping device comprises a second syringe, and the disposable valve comprises an elastomeric valve.

Description

Fluid in the medical injection system is removed
Technical field
Present invention relates in general to the technical field of medical apparatus, particularly, relate to the medical fluid injecting systems that can be used for angiography, computerized axial tomography (CT) or other medical procedures.
Background technology
Some medical procedures, for example the contrast injection in angiographic procedure need be injected liquid (for example, ray contrast contrast medium) patient's vascular system under pressure.In some cases, liquid can be up to 1200 pounds/square inch (psi) or even higher pressure injection.
When carrying out this injection process, may also need measure patient's organism pressure, to carry out the hemodynamics monitoring.For example, in angiography, may need to write down in the blood vessel between the high-pressure injection of contrast medium and the pressure in the heart.Be designed to physiological measurements for example the pressure converter measured of hemodynamics can not bear usually even medium injection pressure, therefore, in injection process, usually must with any high pressure flow insulated.
Summary of the invention
One embodiment of the present of invention provide a kind of method that is used for removing from the injecting systems that possesses power air or liquid.In this embodiment, described method comprises: drive first pumping installations with first operator scheme, to pass through disposable pipe fitting and a certain amount of first liquid medium of disposable valve injection; Drive first pumping installations with second operator scheme, so that the distortion of disposable valve; And drive second pumping installations, with by described disposable pipe fitting and a certain amount of second liquid medium of valve injection of being deformed.In one embodiment, first pumping installations is first syringe, and second pumping installations is second syringe, and disposable valve is a feather valve.
In one embodiment, the type of the valve that uses in possessing the injecting systems of power is deformable valve, for example feather valve.When using in the injecting systems that is possessing power, feather valve can allow the liquid flow forward along a direction, but prevents adverse current in the opposite direction.Before feather valve can be connected on the patient, according to an embodiment, the air of the both sides of valve should be removed.This application discloses and has helped several different methods that air is removed from the both sides of this valve according to some embodiment when carrying out.
Some embodiment of the present invention provides multiple advantage and benefit.For example, some embodiment helps bubble is removed from pipeline, and makes that the amount of needed contrast medium minimizes in injection process.In addition, some embodiment can help the doctor that catheter tip is positioned at home, avoid directly contacting with patient's endarterium, with help to make complication for example the chance of cutting open or boring a hole of blood vessel wall minimize.Shape by filling the hemodynamic signal that fluidic catheter tip returns and fine structure partly help the doctor to assess the position of conduit, so that safety injection.Various embodiment help to reduce the signal attenuation that may be caused by viscous contrast in the pipeline or bubble.
Description of drawings
Fig. 1 is the exploded view of exemplary valve module according to an embodiment of the invention;
Fig. 2 is along the cutaway view of being done with the vertical direction of fluid flow of the exemplary valve module of Fig. 1, shows normality (low pressure) operator scheme;
Fig. 3 is along the cutaway view of being done with the vertical direction of fluid flow of the exemplary valve module of Fig. 1, shows and opens (high pressure) operator scheme;
Fig. 4 is the front view of the example valve assembly of Fig. 1;
Fig. 5 is the perspective view of exemplary valve module according to an embodiment of the invention, shows saline port and output port;
Fig. 6 is the top view of the example valve bodies of Fig. 5;
Fig. 7 is the cross section of doing in A-A place, the position of the example valve bodies of Fig. 6;
Fig. 8 is the details drawing of the indicated part (B) of Fig. 7;
Fig. 9 (a)-(c) shows a plurality of views of exemplary disc keeper according to an embodiment of the invention;
Fig. 9 (d) and 9 (e) show the different views of exemplary valve disc according to an embodiment of the invention;
Figure 10 (a)-(g) shows the various views of the optional embodiment of valve module;
Figure 11 (a)-(g) shows the various views of another optional embodiment of valve module;
Figure 12 is the sketch of an embodiment that possesses the injecting systems of power, and described injecting systems can be used for carrying out various functions, and can be connected to valve module in the time can operating;
Figure 13 is the sketch of another embodiment that possesses the injecting systems of power, and described injecting systems can be used for carrying out various functions, and can be connected to valve module in the time can operating;
Figure 14 is the flow chart according to the method that can be carried out by the injecting systems that possesses power of an embodiment; And
Figure 15 is the flow chart according to the method that can be carried out by the injecting systems that possesses power of another embodiment.
The specific embodiment
Referring to Fig. 1, the exemplary embodiment of high-pressure activated valve is described.Exemplary low, high-pressure elastomeric valve comprises dish keeper 101, intermediate valve disk 102 and valve body 103.Valve body 103 and dish keeper 102 are made by polymer, for example polycarbonate of relative stiffness, and valve disc 102 forms and the center has slot by elastomer, preferred silicone rubber are molded.
Resilient disc 102 with slot is clipped between valve body 103 and the dish keeper 101, and at the periphery place of dish by attaching.This attaching can for example be passed through mounting board, bonding, mechanical or chemical welding or other any measures well known in the art and implement.Valve body 103 and dish keeper 101 for example by sonic welded, UV curable adhesive, mechanical whorl or interlock (interferences) locking or this area may be known other in conjunction with or adhesive technology combine, thereby mounting board firmly coils.
In the exemplary embodiment, valve has at least two, preferred three ports, and described port is communicated with the pipe fitting that installs additional.This port for example is: (a) contrast medium entry port, (b) saline enters and pressure transducer port and (c) patient or outflow port.In the exemplary embodiment, dish keeper 101 comprises this contrast medium entry port, is illustrated in more detail among this Fig. 2 that then describes below.
Referring to Fig. 2, valve body 203 comprises saline/transducer port 220 and patient/outflow port 221.In addition, dish keeper upstream end oral pore 222 is outwards (on flow direction forward, promptly in Fig. 2 from right to left) tapered, form cavity 240 with front at resilient disc 202, make: when fluid is advanced by hole 222 and entered into empty cavity, air is compelled to from cavity (being eliminated air) by dish slot 241 and enter valve body 203 (more accurately, enter in the valve body that is suitable for fluid flow cavity).Therefore, for example, in aforesaid angiographic procedure, thereby when cavity 240 build-up pressures of the sky of contrast medium filling dish keeper 201, elastomeric valve disc 202 bendings are also finally opened slot 241 and (are taken place under certain pressure, be called and be called " opening pressure " at this), to inject a fluid in the valve body.The size of cavity makes the may command opening pressure; Under setting pressure, make the big surface of dish stand described pressure increase is acted on power on the dish, thereby reduce opening pressure.Illustrating in greater detail slot among the Fig. 3 that is described below opens and the situation of fluid when entry port 222 flows through slot and enters valve body 203.
Please continue referring to Fig. 2, in the exemplary embodiment, valve body 203 has two inner taper: comprise the narrow tapered portion 205 of the most approaching dish 202 of saline port and the tapered portion 206 of second broad.When operation, when pressure is set up and before fluid is by dish 202, make that near the narrow tapered portion of coiling 202 saline/transducer port 220 can be sealed.The tapered portion 206 of second broad produces for expansible space for dish with relevant cavity, opens fully to allow slot 241.Shrink angle (on flow direction forward) and also impel air is gone out from valve, making does not have bubble to wait behind.
The example valve of Fig. 2 when Fig. 3 shows and is in above-mentioned high-pressure fluid and flows state.With reference to figure 3, contrast fluid under high pressure flows through entry port 322.This has made the pressure that is applied to dish 302 right side surpass " opening pressure ", and this makes dish 302 expand in (or in Fig. 3 to the left) on the flow direction, thereby opens dish slot 341.When dish expanded, it covered the opening of saline/transducer port 302 in the cavity of valve body 303.Simultaneously, remain on the power of dish on 302 and in high-pressure fluid flows process, keep saline port to close by entering fluid, for example in the contrast fluid injection, stood like that.First tapered portion for example has circular passage 350, and saline port 320 is positioned at 350 places, described circular passage, thereby makes the inside of valve body 303 can be full of saline fully in initial setting up (setup) process.In the exemplary embodiment, the remainder of valve body 303 and the turning of passage are preferably slick and sly, to prevent to accompany any bubble in setting up procedure.In addition, this passage helps to remove air by the vacuum of using syringe manually to apply.
In the exemplary embodiment, valve can be used for low pressure to highly compressed medical fluid injection.It also can use with CT, MRI and heart disease contrast media injection systems.In addition, the valve of having removed the two-port form of saline/transducer port 320 can enough be made to serve as check-valves economically.Therefore this high/low pressure valve is made cheaply, has simple design, and comprises three moulding parts can assembling and combine.
The dish keeper comprises the fluid entry port, and in the exemplary embodiment can be for example by Merlon, PET, acrylic acid or may known other any hard polymer moldings that stand high pressure in this area form or machined forms.In exemplary embodiment of the present invention, resilient disc 202,302 is preferably circular, and for example can moldedly form or by lamellar silicone rubber or for example comprise that other elastomers cuttings of Merlon and latex form.In the exemplary embodiment, the performance of resilient disc material for example is: hardness is in the scope of 40-70A, more specifically for example for 55A, and tension length is 1000-1500psi, and percentage elongation is 300-700%, and tearing strength is 150-300lbs./inch.In the exemplary embodiment, the thickness of dish can be 0.060 ", or its thickness can be according to hardness, fluid and slot size 0.020 " to 0.200 " and scope in.In the exemplary embodiment, the slot at place is preferably 0.125 in the middle of dish " long, and can be 0.050 " to 0.30 " long.In the exemplary embodiment, dish has 0.580 " preferred working surface diameter, and can be 0.250 " to 2.00 " scope in.
Valve body 203,303 for example can be stood maybe by Merlon, PET, acrylic acid that other any hard polymers of high pressure (for example, up to 1500psi) are molded to form or machined forms.In the exemplary embodiment, it comprises fluid outflow port 221,321 and saline enters/transducer port 220,320.In the exemplary embodiment, the interior shape of valve body has two tapered portion 205,206, first tapered portion and perpendicular are (promptly, with perpendicular to the vertical plane of fluid flow direction, this plane with when the dish residing plane of panel surface almost parallel when not expanding as shown in Figure 2) angles spent as 10 degree-45 of precedent, and be 20 degree in the exemplary embodiment, the width of first tapered portion for example is 0.020 " to 0.500 ", and be 0.115 in the exemplary embodiment ".In the exemplary embodiment, saline enters/transducer port 220,320 is arranged in first tapered portion, makes to coil 202,302 and close saline port 220,320 when fluid tapered portion when injecting systems flows can make.In the exemplary embodiment, second tapered portion can upwards be spent the angle of-90 degree with perpendicular (as mentioned above) precedent as 45, be preferably 0.161 " (degree of depth is that longshore current body flow direction is measured) deeply, supply the dish expansion and slot 241,341 is opened so that the space of fluid by coiling with generation.
In the exemplary embodiment, valve is placed in the valve body 203,303 and assembles by coiling 202,302.Then, dish keeper 201,301 is placed in the valve body 203,303, and two parts for example by mechanical presses together or be threaded togather or UV connects in conjunction with, sonic welded or by any equivalent measure that may be known in the art.Therefore, the rim the whole outward flange mounting board of dish between valve body and dish keeper, in case stopping leak leaks.In the exemplary embodiment, three fluid ports can for example have public affairs or female Rule (Luer) screw thread, to be attached to injecting systems, patient's conduit and saline/transducer system expediently.
Therefore, disc valve adapts to the high and low pressure fluid system.In addition, more than one port can be arranged in the valve body 203,303, and can so close in injection process or open, and 4 saline type ports for example can be arranged, and can be used for different purposes, for example medicine injection, patient's fluid sampling and isolating pressure converter.For example, penetrate in high or low pressure injection in the process of (but being high enough to surpass opening pressure), all this ports can be closed simultaneously, and when injecting systems was in OFF, all these ports all will be opened or be in " ON ", and can use simultaneously or as required.
Fig. 4 is against the front view of fluid flow direction when the contrast fluid output port is seen.Referring to Fig. 4, except contrast fluid output port 421, also can see passage 450, described passage 450 is annular ring portions, the center of described ring is the center of contrast fluid output port and can locatees (invisible among Fig. 4) near the edge of valve disc relatively.As in conjunction with the description that Fig. 3 did, one or more saline/pressure transducer port 420 are in the passage 450.
Fig. 5 is the perspective view (being 103 in Fig. 1) of valve body, shows contrast fluid output port 521 and saline port 520.Being appreciated that can have a plurality of saline port (with respect to Fig. 4 is 450; With respect to Fig. 3 is 350) be arranged on any position in the passage, this will be described below.
Fig. 6 is the top view of valve body 103, and some representational example sizes have been shown in exemplary embodiment shown in Figure 6.The overall diameter of valve body 601 illustrates with a unit, the diameter of contrast fluid output port 621 is shown 0.3 unit, total depth 660 (measuring at this longshore current body flow direction) is shown 0.700 unit, and the degree of depth 661 of the non-tapering part of valve body is shown 0.35 unit.Therefore be appreciated that the size among Fig. 6 only is exemplary, what illustrate is an example of the relation between each size of this device.Other many sizes and the relation between them also are possible, and in fact can want to emphasize or situation about weakening and performance but needed according to device.For example, the degree of depth 662 of conical region is a parameter of control opening pressure.Space in the cavity of valve disc side is big more, makes it that (resistance that air provided in the cavity is less than other resistances that may members provides) is provided forward easily more, and opening pressure is just low more.Therefore, has inversely prroportional relationship between the degree of depth 662 and the opening pressure (" CP ").The area that setting pressure acts on the dish is big more, and the power that acts on the dish is just big more.Therefore, for the constant k that is subjected to some unit decisions, the CP=k/ degree of depth.
Fig. 7 shows the cross section of being done along the line A-A of example valve bodies shown in Figure 6.Referring to Fig. 7, show a plurality of exemplary design sizes, for example the internal diameter 701 of contrast medium output port; The external diameter 702 of this output port; Cavity is communicated to the diameter 703 at the leading edge place of contrast fluid output port 703 at cavity; The diameter that begins to locate 704 of second conical region in valve cavity; The diameter that begins to locate 705 of first conical region in valve cavity; And valve body is at the internal diameter 706 at non-conical region place, and this internal diameter is the diameter that given valve disc will be packed into.As mentioned above, in order not have any escape of liquid, the diameter that is designed to be assemblied in the exemplary disc in the diameter 706 will have identical diameter and closely cooperate guaranteeing.In alternate exemplary embodiment, also can make the diameter of dish slightly larger, thereby guarantee to closely cooperate, in this case, can use and need note preventing the low-down liquid of the viscosity of leaking more.
Can point out,, illustrate the exemplary valve disc that is designed to be assemblied in wherein with horizontal top among Fig. 9 (d), in Fig. 9 (e), show this valve disc with the vertical side view for the exemplary embodiment shown in Fig. 7.Referring to Fig. 9 (d), as can be seen, the diameter of shown exemplary valve disc is 0.83 unit, and is corresponding with the size 706 shown in Fig. 7.Referring to Fig. 7 as can be seen, have by the circle that is labeled as " B " around the zone 750 that illustrates.This zone is shown among Fig. 8, and is then described.
Fig. 8 shows detailed B zone with the ratio of amplifying 6 times with respect to Fig. 7.Detail region shown in Fig. 8 is the intravital exemplary saline port of valve, and this should be conspicuous concerning the reader.Referring to Fig. 8, as can be seen, in this exemplary embodiment, the outside cone angle of valve body departs from perpendicular 60 degree, and in this exemplary embodiment, the corner part that begins at the outer surface of valve body from the male-tapered zone to the distance 801 at the center of saline port is 0.192 unit.In addition, in this exemplary embodiment, the angle 802 of the angle of the expression inner taper or first tapered portion 205 (referring to Fig. 2) is illustrated as 30 degree.The exemplary diameter 810 of saline port is 0.169 unit.In addition, referring to Fig. 8, Reference numeral 803 expressions are used for manually removing the channel depth of air (if remove automatically from the transducer side of system, then do not need), Reference numeral 804 expressions are used for closing at injection process the main cone degree (primary taper) of the valve body of saline/transducer port, Reference numeral 805 expressions are used for the position of the impression body (indent) of clamping valve disc reliably, and Reference numeral 806 expressions are used for the height of the impression body of clamping disk.
To 9 (c), show each view of dish keeper 101 (referring to Fig. 1) referring to Fig. 9 (a) with following exemplary dimensions.Referring to Fig. 9 (a), exemplary outer diameter 901 is 0.83 unit.Should be pointed out that this size is corresponding with the key element 706 among Fig. 7, it accurately is the exemplary dimensions of internal diameter that enters the non-tapering part of valve body, and the dish keeper will be assemblied in the described non-tapering part.In addition, the exemplary internal diameter of the exemplary disc keeper shown in Reference numeral 902-905 represents, referring to Fig. 9 (c), Reference numeral 910 shows the exemplary diameter of the main portion of exemplary disc keeper, Reference numeral 911 shows the exemplary outer diameter of high voltage input terminal mouth, Reference numeral 912 shows the exemplary internal diameter of high voltage input terminal mouth, Reference numeral 914 shows the example port size that is used to produce enough pressure, Reference numeral 915 shows the exemplary cavity size that is used to produce pressure, and Reference numeral 908 shows the exemplary cavity angle (with respect to perpendicular) that is used for exemplary cavity.
Referring to Fig. 9 (d) and 9 (e), show the view and the exemplary dimensions thereof that are used for exemplary valve disc.Referring to Fig. 9 (d), as mentioned above, the exemplary outer diameter of valve disc is illustrated as 0.83 unit.Exemplary disc length is shown 0.15 unit.Should be pointed out that for the relation between the diameter of dish length and valve disc, make:, also can not worry the leakage at the periphery place of valve disc even open fully when the valve disc slot.
Therefore, one or more other saline port can be located at any position in the annular ring portion, and described annular ring portion is represented as passage 350 in Fig. 3, and when the configuration of valve shown in Figure 3 occurring, described saline port is identical and be closed simultaneously.Referring to Fig. 9 (e), show the thickness of valve disc, be the thickness of 0.06 unit in the exemplary thickness of this valve disc that illustrates in this exemplary embodiment.
According to an embodiment, design parameter is used to set the opening pressure of valve.Usually, opening pressure is the function of the main cone degree of the hardness of disc thickness, slit length, resilient disc and valve body.Opening pressure increases along with the increase of disc thickness and disk material hardness, and opening pressure reduces along with the reducing of main cone degree of slit length of coiling and valve body.
Figure 10 (a)-10 (g) shows each view of the optional embodiment of valve module.In this embodiment, valve module comprise the valve keeper or cover 1008, feather valve 1010 and valve body or housing 1000.This assembly also comprises first input end mouth 1006, second input port 1004 and output port 1002.Figure 10 (a) shows the decomposition view of valve module, wherein has each separating member 1000,1008 and 1010.In this embodiment, the first input end mouth is connected to valve keeper 1008, and second input port 1004 and output port 1002 are connected to valve body 1000.In one embodiment, feather valve 1010 comprises disc valve.
In one embodiment, first input end mouth 1006 is along first axle alignment, described first axle and valve body 1000 general tangential.In one embodiment, first axle and valve body 1000 approximate vertical and tangent.In one embodiment, first axle and the localized area or the volumetric spaces general tangential that are included in the valve body 1000, and also can with the zone or the volumetric spaces approximate vertical of this qualification.Figure 10 (a) and Figure 10 (e) show this first axle how can with the example of the cross section of valve body 1000 (its also with by valve 1010 and valve keeper 1008 coplanes) approximate vertical.These figure also show first axle how also with the example of valve body 1000 general tangential.This collocation form make to inject and the fluid by first input end mouth 1006 can inject tangently and pass through valve body 1000 and from output port 1002 discharges.By this design, valve module provides a kind of efficient and effective method that air (being bubble) is removed from assembly.
In fluid injection system, the air that may be included in the valve module can cause some problem.For example, air can disturb and twist the heart blood power signal potentially, and described signal is by pressure converter, for example be connected to the changer sensing or the monitoring of the transducer port 1014 of valve module.In operation process, these hemodynamic signal are used for the doctor, with the catheter tip guiding that will be connected to output port 1002 safely be placed on home in the heart.In addition, exist any air that is included in the valve module may import patient's danger potentially.
In one embodiment, second input port 1004 is connected to valve input port 1015 (preferably referring to Figure 10 (b)), and the valve input port is along second axial alignment, described second axis and valve body 1000 general tangential.In one embodiment, the first axle approximate vertical of this second axis and first input end mouth 1006.In one embodiment, localized area or the volumetric spaces general tangential in second axis and the valve body 1000.By by means of the first input end mouth 1006 and second input port 1004 valve module being passed through in the fluid injection, these fluids can be with respect to valve body 1000 tangential injection.According to an embodiment, the fluid port of tangential alignment, for example port one 006 and 1004 make injection advance along spiral path by the medical fluid of this port.This spiral fluid flows can be discharged port 1020 (preferably referring to Figure 10 (c)) with clearing out of attached to the bubble of the periphery of valve.This screw action can be enough in any orientation of valve module bubble be removed from feather valve 1010.By improving efficient and the effectiveness that air removes in the valve module, can provide the hemodynamic signal of improvement to the pressure converter of the transducer port 1014 that is connected to valve module, and the chance that also may make air import among the patient is littler.
In one embodiment, valve keeper 1008 comprises the dish keeper, and valve 1010 comprises elastomeric valve disc.Can find out from Figure 10 (a) preferably that valve 1010 comprises one or more slots (such slot 1012 is shown among Figure 10 (a)).In this embodiment, slot 1012 is placed in the middle in valve 1010.When feather valve 1010 was in closed condition, first input end mouth 1006 was isolated with output port 1002 and second input port 1004 (together with the pressure converter that can be connected to transducer port 1014).At this state, fluid can not flow to output port 1002 from first input end mouth 1006, but fluid (for example, diluent, saline) can flow to output port 1002 from second input port 1004, and the pressure converter that is connected to transducer port 1014 can be surveyed the hemodynamic signal of monitoring from the patient's pipeline that is connected to output port 1002.
When feather valve 1010 was in open mode, second input port 1004 and transducer port 1014 isolated with output port 1002 and first input end mouth 1006, and the first input end mouth becomes to be communicated with output port 1002 for 1006 this moments, to be used for fluid flow.When entering and fluid pressure by first input end mouth 1006 when equaling or exceeding the pressure of qualification and making that valve is opened (for example, opening by making the slot 1012 shown in Figure 10 (a)), valve 1010 is in open mode.In open mode, fluid can enter valve body 1000 from the slot 1012 that first input end mouth 1006 flows through valve 1010, discharge output port 1002 then, but second input port 1004 and transducer port 1014 separate (damaging because of this high-pressure spray so that for example prevent the pressure converter that is connected to port one 014) with elevated pressures stream.By adopting this mode, Figure 10 (a) to the feather valve assembly shown in Figure 10 (e) with embodiment (previously described) above the feather valve in the application similarly mode operate.
In one embodiment, the state of valve (for example valve disc 1010 shown in Figure 10 (a)) is determined by being applied to the pressure that is used on the first input end mouth 1006 fluid is entered.In one embodiment, the pressure of qualification comprises the opening pressure that is used to make the valve 1010 that slot 1012 opens.In one embodiment, opening pressure is the physical property of feather valve 1010, the inside dimension of valve keeper 1008, valve body 1000 and/or valve 1010, or at least one the function in the external dimensions of valve keeper 1008, valve body 1000 and/or valve 1010.
In one embodiment, second input port 1004 is connected to double check valve 1030, shown in Figure 10 (f).In certain embodiments, can use flexible rubber check-valves (duck bill) or based on the double check valve of spring.In other embodiments, also can use other forms of double check valve.Double check valve 1030 makes fluid to flow through described check-valves from outer tube and flows into second input port 1004, flows out output port 1002 then by housing 1000.Passing through first input end mouth 1006 to the high-pressure fluid injection process of output port 1002, double check valve 1030 can be further used for preventing that the pressure converter that is connected to transducer port 1014 is subjected to the high pressure effect, and this high pressure may damage changer potentially.In this case, double check valve 1030 can provide pressure relief, and whereby, higher pressure can be passed by housing 1000, second input port 1004, check-valves 1030 and passes out the pipe fitting that is connected to check-valves 1030 to passback.The pipe fitting compliance is enough to reduce the overvoltage burden that acts on the changer.In addition, in certain embodiments, double check valve 1030 can provide the function with hemodynamic signal reflected back changer, thereby prevents hemodynamic signal decay or weakened.
Figure 10 (b) shows the front view of the embodiment of the valve module shown in Figure 10 (a).Can in Figure 10 (b), find out, axis by valve input port 1015 (it is connected to second input port 1004 and is also connected to transducer port 1014) along the direction tangent with valve body 1000 (for example, with valve body 1000 in localized area or volumetric spaces tangent) extend.Figure 10 (b) also shows valve body 1000 and comprises a plurality of reinforcement classes 1016.These ribs 1016 help to strengthen and support valve body 1000 and realize stablizing.According to the present invention, rib 1016 helps to adapt to high pressure, makes valve module can significantly not be out of shape or explosion.
Figure 10 (c) shows the top view of the embodiment of the valve module shown in Figure 10 (a).The figure shows: in one embodiment, first input end mouth 1004, second input port 1006 and output port 1002 can be all along the settings that parallels to the axis.Figure 10 (c) also illustrates in greater detail transducer port 1014.Transducer port 1014 comprises the seat 1018 that is used for pressure converter is connected to port one 014.Also show and discharge port 1020, this discharge port 1020 makes that air can be discharged from valve module in use.In the process of fluid tangential injection by input port 1004 and/or 1006, possible bubble can be removed from valve module by discharging port 1020.
Figure 10 (d) shows the optional view of the valve module shown in Figure 10 (a).Figure 10 (a) shows the decomposition view of the member of valve module, and Figure 10 (d) shows the side view that assembles/make good valve module.
Figure 10 (e) shows the rearview of the embodiment of the valve module shown in Figure 10 (a).The fluid that Figure 10 (e) shows by 1006 injections of first input end mouth is how can inject described axis and valve body 1000 approximate vertical and tangent (also with valve keeper 1008 approximate vertical) along axis.In addition, Figure 10 (e) show by injection by second input port 1004, enter and fluid by valve input port 1015 is how can be along the injection of (port one 015) axis, described axis and valve body 1000 general tangential.
Figure 10 (f) shows the view of the embodiment of the valve module of describing in front that is connected to double check valve 1030.Double check valve 1030 is connected to second input port 1004.
Figure 10 (g) shows the cutaway view according to the feather valve 1010 shown in Figure 10 (a) of an embodiment.Figure 10 (g) shows the example as the slot 1012 of angled slit.In one embodiment, angled slit 1012 is located along an axis, and wherein, the angle between the horizontal axis of this axis and Figure 10 (g) is limited in the scope of 5 degree-30 degree.In other embodiments, also can use the structure of different angles.In one embodiment, in the fluid injection process, angled slit 1012 can be opened, and flows through valve 1010 and flows out to output port 1002 (among Figure 10 (g), along direction from right to left) from syringe so that allow.
Figure 11 (a) shows the various views of another optional embodiment of valve module to 11 (g).The optional embodiment of this of valve module and Figure 10 (a) are similar to the embodiment shown in 10 (g), but do not have pressure transducer port.Figure 11 (a) shows the decomposition view of this optional embodiment, and wherein, the discharge port 1120 of valve module can be connected to the transducer port and the pressure converter of external discrete.Under the situation of this design, user can couple together the external pressure changer of valve module and dissimilar, shape or design, described external pressure changer monitoring propagate from the patient and hemodynamics waveshape signal by valve module (via output port 1102 and discharge port 1120) can use with valve module.Figure 11 (a) also comprises first input end mouth 1106, valve keeper 1108, second input port 1104, feather valve 1110 (for example disc valve), slot 1112 (for example middle slot in valve 1110), valve body 1100, output port 1102, discharges port 1120, valve input port 1115 (it is connected to and discharges the port 1120 and second input port 1104) and ribs 1116 to the optional embodiment of the valve module shown in 11 (g).
In one embodiment, second input port 1104 is connected to double check valve 1130, shown in Figure 11 (f).In certain embodiments, can use flexible rubber check-valves or based on the double check valve of spring.In other embodiments, also can use other forms of double check valve.Double check valve 1130 makes fluid to flow through described check-valves from outer tube and flows into second input port 1104, flows out output port 1102 then by housing 1100.Passing through first input end mouth 1106 to the high-pressure fluid injection process of output port 1102, double check valve 1130 can be further used for preventing to be connected to the pressure converter of discharging port 1120 and be subjected to the high pressure effect, and this high pressure may damage changer potentially.In this case, double check valve 1130 can provide pressure relief, and whereby, higher pressure can be passed by housing 1100, second input port 1104, check-valves 1130 and passes out the pipe fitting that is connected to check-valves 1130 to passback.The pipe fitting compliance is enough to reduce the overvoltage burden that acts on the changer.In addition, in certain embodiments, double check valve 1130 can provide the function with hemodynamic signal reflected back changer, thereby prevents hemodynamic signal decay or weakened.
Figure 11 (g) shows the cutaway view according to the feather valve 1110 shown in Figure 11 (a) of an embodiment.Figure 11 (g) shows the example as the slot 1112 of angled slit.In one embodiment, angled slit 1112 is located along an axis, and wherein, the angle between the horizontal axis of this axis and Figure 11 (g) is limited in the scope of 5 degree-30 degree.In other embodiments, also can use the structure of different angles.In one embodiment, in the fluid injection process, angled slit 1112 can be opened, and flows through valve 1110 and flows out to output port 1102 (among Figure 11 (g), along direction from right to left) from syringe so that allow.
The embodiment of the valve module shown in Figure 10 to 11 and other embodiment can provide multiple benefit.For example, the medical fluid (for example, contrast medium or saline) that is injected in the valve of the fluid input port by tangential alignment helps to provide spiral fluid flows in valve.This spiral fluid flows can help and will clear out of the discharge port safely in the valve or attached to the potential air (for example, bubble) of the periphery of valve.In the fluid injection process, also have around the outward flange of valve with through the high velocity fluid flow of the whole volumetric spaces of valve.This can provide some advantage.For example, can realize enhanced bubble removal effect potentially in the orientation (orientation when depending on the parts that inserting and be used as the patient's apparatus in the fluid injection system) of any feather valve.The chance that this advantage helps to make air import the patient in medical procedure minimizes.In addition, can realize the integrity of the hemodynamic signal improved, wherein, can be sensed more effectively and accurately by pressure converter or corresponding monitoring system and measure from patient's hemodynamic signal.But the hemodynamics monitoring system is then Xiang doctor's display waveform, so that the accurate feedback information about the intrasystem pressure of patient vessel to be provided in operation process.This information can help the doctor in many ways, for example helps to change the incorrect placement (it can help to reduce the potential incidence rate of arteriotomy at last) of patient's conduit.
Figure 12 is the sketch of an embodiment that possesses the injecting systems 1200 of power, and described injecting systems 1200 can be used for carrying out various functions, and can be connected to valve module in the medical science aseptic area in the time can operating, for example the embodiment of Shang Mian valve module.The injecting systems that possesses power 1200 shown in Figure 12 be used in the medical procedures (for example, in angiography or CT process) in aseptic area with medical fluid, for example contrast medium or saline injection to the patient.According to an embodiment, valve module, the assembly that for example comprises feather valve can be connected to system 1200, and can use in aseptic area in the whole process of corrective surgery.System 1200 comprises multiple member, for example, control panel 1202, hand controls connector 1204, hand controls 1212, fluid reservoir 1206, pipe fitting 1208, pump 1210, pressure converter 1218, fluid reservoir 1214, syringe 1216, high-pressure injection pipe fitting 1222, valve 1220, air detectors 1224 and stopcock 1226.In greater detail among embodiment, fluid reservoir 1206 comprises container below, for example bag of diluent (for example saline) or bottle, and fluid reservoir 1214 comprises container, for example bag of contrast medium or bottle, pump 1210 is peristaltic pumps.In other embodiments, pump 1210 can be other forms of pumping installations, for example syringe, gear pump or other forms of positive displacement pump.In certain embodiments, high-pressure fluid is injected to the pumping installations of delivering to the patient for other forms of as the syringe 1216 (together with its relevant plunger) of pumping installations is replaceable.Single pumping installations can or work with difference or multiple modes of operation operation.For example, a kind of pumping installations can be operated like this: make fluid along first direction (for example, pumping fluid movably forward), and it also can be operated like this: along second direction (for example when activateding or drive, rightabout, back mutually) moves, to carry out some function.
Operator can use control panel 1202 to set various parameters and/or the agreement that will use in given process.Pump 1210 can be used for via saline pipe fitting 1208, valve 1220 and high-pressure pipe member 1222 saline being pumped into the patient from bag.In one embodiment, valve 1220 comprises the spool valve based on spring well known in the art.In one embodiment, valve 1220 comprises based on elastomeric valve, for example the embodiment of the feather valve of describing in this application.The various embodiment of disclosed valve can be used in the system of Figure 12 in this application.
In one embodiment, syringe 1216 is used for contrast medium is extracted into syringe 1216 from bin 1214, and will be from the contrast injection of syringe 1216 in the patient via valve 1220 and high-pressure pipe member 1222.In one embodiment, syringe 1216 is self-purging syringes, and this syringe has one and is used for filling contrast medium and removes the port of air and be used for second port of inject contrast.
As the description that the operation of top various embodiment at valve is done, being communicated with between the input port that valve 1220 is used to be controlled to valve 1220 and the output port.In one embodiment, valve comprises two input ports, and one of them port is connected to contrast fluid line, and another port is connected to saline fluid line.Saline fluid line also comprises pressure converter 1218.
Stopcock 1226 regulated fluid flow to the patient's.In one embodiment, valve 1220 can make saline line or contrast medium pipeline connection to patient's (high-pressure pipe member) pipeline 1222.When syringe 1216 was used for inject contrast, valve 1220 made contrast medium can flow to patient's pipeline 1222, but stoped saline to flow to patient's pipeline 1222.In the high-pressure injection process, pressure converter 1218 is also isolated with patient's pipeline 1222, thereby prevents that changer 1218 is subjected to being accompanied by the high injection pressure of contrast injection.When not having contrast medium from syringe 1216 injection, valve 1220 makes contrast medium pipeline and 1222 isolation of patient's pipeline, but opens being communicated with between saline line (pipe fitting) 1208 and the patient's pipeline 1222.At this state, pump 1210 can inject saline among the patient, and pressure converter 1218 also can be via the hemodynamic signal of patient's pipeline 1222 monitoring from the patient, and produces representational electronic signal based on the pressure of measuring.
The system 1200 of Figure 12 also shows hand controls 1212 and air detectors 1224.Operator can use hand controls 1212 manually to control the injection of saline and/or contrast medium.Operator can press a button on the hand controls 1212 with pump pickle, and can press other buttons with inject contrast.In one embodiment, operator can press contrast button, send contrast medium so that give with variable flow rate.It is severe more that operator press button, just has big more contrast medium flow rate to give and deliver to the patient.Also can use other controllers, for example foot-operated controller.Possible bubble or gas column that air detectors 1224 is surveyed in the high-pressure pipe member 1222.In one embodiment, air detectors 1224 is based on the detector of ultrasound wave or sound.In other embodiments, air detectors 1224 also can use infrared ray or other detection methods (for example optics).Have air if air detectors 1224 detects in the high-pressure pipe member 1222, it produces the signal that is used for alert operator and/or ends injection process.
Figure 13 is the sketch of another embodiment that possesses the injecting systems 1300 of power, and described injecting systems 1300 can be used for carrying out various functions, and can be connected to valve module in the medical science aseptic area in the time can operating, for example the embodiment of Shang Mian valve module.The injecting systems that possesses power 1300 shown in Figure 13 be used in the medical procedures (for example, in angiography or CT process) in aseptic area with medical fluid, for example contrast medium or saline injection to the patient.According to an embodiment, valve module, the assembly that for example comprises feather valve can be connected to system 1300, and can use in aseptic area in the whole process of corrective surgery.
System 1300 is a kind of double syringe systems, and described double syringe system comprises control panel 1302 and two motor/actuator 1303a and 1303b.Each motor is a linear actuators among driven unit 1303a, the 1303b correspondingly.Plunger among syringe 1308a of each linear actuator drives or the 1308b.Single plunger is along forward direction or back to moving in the syringe barrel of syringe 1308a or 1308b.When along forward motion, plunger goes out syringe with liquid infusion and delivers in the liquid container (for example bottle) in patient's pipeline or with air purge.When along the back when mobile, plunger from liquid container with liquid fill to syringe 1308a, 1308b.Figure 13 shows the example of two such liquid containers 1304 and 1306.In one embodiment, container 1304 is bag or the bottles that comprise contrast agent, and container 1306 is to comprise diluent, for example brinish bag or bottle.In other embodiments, being respectively syringe 1308a, the 1308b (together with relevant plunger) of pumping installations can be individually or jointly comprise can be with suitable flow rate/pressure/the wait pumping installations of another form of injecting fluid, for example positive displacement pump of peristaltic pump or another form.Single pumping installations can or work with different, multiple modes of operation operation.For example, a kind of pumping installations can be operated like this: make fluid along first direction (for example, pumping fluid movably forward), and it also can be operated like this: along second direction (for example when activateding or drive, rightabout, back mutually) moves, to carry out some function.
Many groups pinch valve/air probe assembly has been shown among Figure 13.One group of pinch valve/air probe assembly 1310a is connected between the syringe input port of liquid container 1306 and syringe 1308a, and the second pinch valve/air probe assembly 1312a is connected between the syringe output port and patient's connector of syringe 1308a.The 3rd pinch valve/air probe assembly 1310b is connected between the syringe input port of liquid container 1304 and syringe 1308b, and the 4th pinch valve/air probe assembly 1312b is connected between the syringe output port and patient's connector of syringe 1308b.In the embodiment shown in fig. 13, each syringe 1308a, 1308b are the dual-port syringes.Fluid flows and is drawn onto syringe 1308a or the 1308b from container via the syringe input port, and fluid flows out syringe 1308a or 1308b via the syringe output port and from syringe 1308a or 1308b injection.
Each pinch valve among pinch valve/air probe assembly 1310a, 1310b, 1312a, the 1312b can be opened or closed by system 1300, leads to or is communicated with away from the fluid of each syringe 1308a, 1308b with control.Air acquisition sensor among assembly 1310a, 1310b, 1312a, the 1312b can be optical, sound wave or other forms of pick off.These pick offs help to survey and may be arranged in the air that leads to or be communicated with away from the fluid of syringe 1308a, 1308b.When the one or more pick offs generations in these pick offs were illustrated in the signal that may have air in the fluid circuit, system 1300 can warn the user or stop injection process.In system 1300, use a plurality of pinch valves to make system 1300 optionally to control the fluid inflow or to flow out syringe 1308a, 1308b automatically or by user intervention by opening or closing the fluid pipe fitting.In one embodiment, system's 1300 each pinch valve of control.Use a plurality of air acquisition sensors to help to lead to or away from the overall security of the possible air in the fluid (in pipe fitting) of syringe 1308a, 1308b (for example, gas column, bubble) raising system 1300 by detection.Signal from air detectors sends to system 1300 and by system's 1300 processing, makes system 1300 that warning or termination injection process can for example be provided when detecting air.In the example of Figure 13, fluid at first flows through pinch valve, then the air detectors in flowing through component 1310a, 1310b, 1312a, the 1312b.In other embodiments, pinch valve and the air detectors in these assemblies can use other collocation forms, ordering etc.And, the alternative pinch valve of the valve of other types.
Operator can use control panel 1302 initialization, injecting systems 1300 is set at one or more injection process, and can further use one or more parameters (for example, flow rate, fluidic volume, pressure limit, the rise time of sending will be given) of each injection process of control panel 1302 configuration.Operator also can use panel 1302 to suspend, recover or finish injection process and begin a new process.Control panel also shows the various information relevant with injection to operator, for example, and flow rate, volume, pressure, rise time, procedure type, fluid information and patient information.In one embodiment, control panel 1302 can be connected to scanning bed, is electrically connected to the main syringe of system 1300 simultaneously.In this embodiment, operator can arrive the position of expectation by artificial mobile control panel 1302, still can realize all functions that panel 1302 provides simultaneously.
The system of Figure 13 also comprises valve 1314, and described valve 1314 is connected to the output pipe that is derived from syringe 1308a and 1308b.The output of each syringe provides the fluid by the pipe fitting injection of the input of leading to valve 1314 through pinch valve/air probe assembly 1312a or 1312b then.In one embodiment, a fluid circuit to valve 1314 also comprises pressure converter.The valve output port of valve 1314 is connected to pressure duct, and described pressure duct is used for fluid is directed to the patient.In one embodiment, valve 1314 is made by flexible material, the elastomeric material for example described in each embodiment of above-mentioned feather valve.In one embodiment, valve 1314 is feather valves, for example the embodiment of the valve of describing in this application.Valve 1314 makes the fluid circuit (for example, contrast medium pipeline or saline line) in the fluid circuit can be communicated to patient's (high-pressure pipe member) pipeline.When saline and contrast medium are included among syringe 1308a and the 1308b respectively, valve 1314 makes contrast medium to flow to patient's pipeline (if air is opened and do not detected to the pinch valve the assembly 1312b) from syringe 1308b, but stops saline to flow to patient's pipeline from syringe 1308a.The pressure converter (according to an embodiment) that is connected to saline line also by with patient's line isolation, thereby prevent that changer is subjected to being accompanied by the high injection pressure of contrast injection.When not having contrast medium when syringe 1308b injects, valve 1314 is contrast medium pipeline and patient's line isolation, but allows from being connected between the saline line of syringe 1306 and the patient's pipeline.Syringe 1308a can inject saline into (if air is opened and do not detected to the pinch valve among the assembly 1312a) among the patient, and pressure converter can also be via the patient's pipeline monitoring hemodynamic signal from the patient, and based on producing representational electronic signal by the gaging pressure that system 1300 handles.
In one embodiment, the subclass of the function that is provided by main panel 1302 is provided little control panel (not shown).This little control panel can be connected to the syringe in the system 1300.Under a kind of situation, operator can use the setting of small panel management syringe.Small panel can be presented at the guidance that plays help in this process order is set.Small panel can show that also some mistake and failure diagnosis information are to help operator.For example, small panel can to operator send liquid memory and/warning that has low contrast medium or brine fluids level in the syringe.
Figure 14 is the flow chart according to the method that can be carried out by the injecting systems that possesses power of an embodiment.This method can be by the multiple injecting systems that possesses power, and system 1200 for example shown in Figure 12 or system shown in Figure 13 1300 carry out.Sequence of movement shown in Figure 14 only is exemplary.In one embodiment, the injecting systems that possesses power can automatically perform the method shown in Figure 14.In this embodiment, this system can valve with automatically perform this method after relevant pipe fitting is mounted or after operator begin this method by the manual activation request on control or small panel.According to an embodiment, thus method be performed be ready to this system after, valve and relevant member can be connected to the patient's conduit line in the patient infusion process is used.
The injecting systems that possesses power can at first be carried out initial saline purge.When initial, before using, the flexible valves, for example feather valve that can be used in this system may be filled with air.Usually, operator take out with relevant member/pipe fitting disposable valve from sterile bag, be connected to the remainder of injecting systems then.Before valve was used for medical procedure, it may comprise the air that needs are removed.In order to help to realize this air purge, saline at first injects by pumping installations, for example peristaltic pump or syringe and the saline port by valve.In one exemplary embodiment, saline can with greater than the speed of 2ml/ second with the volume injection more than the twice of the total measurement (volume) of valve and relevant disposable pipe fitting thereof.In other embodiments, the flow rate injection that saline can be lower.This operation helps air is removed with the pressure converter that is connected to saline line from preceding (saline) side of valve.After initial saline was removed, the front side of valve can stop contrast medium to be back to transducer element.Then, be closed to the connection of saline pumping installations, to prevent to inject other saline.For example, in system shown in Figure 13, the pinch valve between saline syringe output port and flexibility (for example elasticity) valve can be closed.
According to an embodiment, this system also carries out contrast purge operation.This is a kind of strong contrast material injecting step, described step in the high-pressure side or the contrast medium side contrast medium is injected and is passed through flexible valves from contrast medium pumping installations (for example, syringe).In one exemplary embodiment, contrast medium is with greater than the speed of 2ml/ second with the volume injection more than the twice of the total measurement (volume) of elastic valve body product space.In other embodiments, the flow rate injection that contrast medium can be lower.In some cases, can be sent to brine side from a plurality of bubbles of the contrast medium side of valve, and can remove by saline purge subsequently, as described below.
Next action shown in the example of Figure 14 is valve pullback operation (for example, when using flexibility or feather valve).In contrast injection procedure, flexible valves can be heaved, and even when pressure descends also retaining part heave.Pullback operation produces bigger space with the withdrawal of valve element with the brine side at valve.The final saline that describes below is removed and any residual bubble can be removed from valve then.According to an embodiment, can note not pulling back too far or too fast, because this may cause the contrast medium side with the bubble inlet valve of brine side.In addition, also can produce in the contrast medium side can be with the vacuum pressure of gas sucking-off solution, as described below.The valve pullback operation is carried out by withdrawal plunger in comprising the pumping installations of contrast medium.
This system also can carry out the operation of contrast medium isostasy.But make to feather valve pullback operation potentiality vacuum bubbles be formed on back (contrast medium) side of valve.If rest on this vacuum state, these vacuum bubbles can and form actual bubble from contrast medium mixture intake-gas.Be connected (connection) with fluid between the contrast syringe, close this connection then after short delay by opening contrast bottle (it provides fluid to syringe) momently, partial vacuum can alleviate.(for example, in the system shown in Figure 13, the pinch valve between contrast bottle and the contrast medium pumping installations can be opened by of short duration, and is after short prolongation, closed more then).Vacuum bubbles is replaced by the contrast medium from the contrast bottle bin.
The injecting systems that possesses power also can be carried out final saline and remove, described in the method as shown in Figure 14 like that.In one embodiment, saline can be once more with greater than the speed of 2ml/ second and with the volume injection more than the twice of the total measurement (volume) of flexible valves and pipe fitting.In other embodiments, the flow rate injection that saline can be lower.This operation can be removed air from the front side and the pressure converter on saline line of valve.Whole valve and pipe fitting can be eliminated bubble then.On this aspect, according to an embodiment, valve can be connected to patient's conduit safely.In system shown in Figure 13, according to an embodiment, all pinch valves can valve with all be closed before relevant pipe fitting is connected to patient's conduit.
When carrying out saline or contrast purge operation, system can make saline or contrast medium pumping installations with some pattern operation, for example removes to carry out fluid by the pump that moves up in designated parties.When carrying out pullback operation, system can make relevant pumping installations (for example, the contrast medium pumping installations) with other pattern operations, for example by moving pump along other direction to pull back.For example, in system 1200 or 1300, system can make contrast medium pumping installations (syringe is as shown in example) move along first direction, but the contrast medium pumping installations is moved with the feather valve of pulling back along second (for example, opposite) direction.
Method shown in Figure 14 can provide some advantage and benefit.For example, all provide enhanced bubble to remove effect under the orientation of the method for so carrying out any flexibility (for example, elasticity) valve that can in system, use.In addition, by carrying out this method, the bubble that the injecting systems that possesses power can be used for helping reducing the downstream that may be arranged in air detectors is injected into patient's probability.This system also can be by removing the integrity that problematic bubble provides the hemodynamic signal of improvement the fluid circuit between patient and pressure converter.
Figure 15 is the flow chart according to the method that can carry out by the injecting systems that possesses power of another embodiment.This method can by variously possess the injecting systems of power, for example system 1200 shown in Figure 12 or system 1300 shown in Figure 13 carry out.Sequence of movement shown in Figure 15 only is exemplary.Contrast injection can comprise the perhaps many additional move of action, and this depends on special applications and the processing of hemodynamic signal in system.In one embodiment, the injecting systems that possesses power can automatically be carried out method shown in Figure 15.
As shown in figure 15, the initial actuating in this method can comprise contrast injection action.This action comprises strong contrast material injection, contrast medium is given the desired location of delivering among the patient.The injecting systems that possesses power of carrying out this method can suspend then after given contrast injection procedure that to be used for system's compliance lax.In strong contrast injection procedure, the flexible member in the contrast fluid path can stand high pressure (for example, 1200psi) with pressure expansion.The expansible components relax of chien shih or lose their compliance when this may need some.When components relax, pressure descends.Before further step began, injecting systems can suspend a period of time, so that pressure descends.This time-out can be very short interval (even being the zero-time), if also can longer (for example, disposable compliance, pipe fitting compliance and conduit size etc.) when perhaps system needs.
System can carry out the valve pullback operation then, as shown in figure 15.This pullback operation is by the operation of corresponding pumping installations, for example the withdrawal by the syringe plunger in the contrast syringe realizes.Flexible valves, for example feather valve can make contrast medium flow to the patient forward and prevent adverse current.Flexible member also can play second kind of function by the distortion under high-pressure flow, the hemodynamics transducer element that is positioned at pressure sensor there with the low-pressure port and the protection of preceding (saline) side of draught excluder.In contrast injection procedure, flexible element bulges, and even still may the retaining part protuberance when under pressure, rolling back normal patient's pressure.The valve of part protuberance can partly be blocked the path to changer at this moment, and weakens the upper frequency composition of hemodynamic signal.Pullback operation helps the retract valve element and makes changer obtain complete hemodynamic signal.Along with the withdrawal of flexible valves, it makes the volume of preceding (saline) side of valve enlarge little amount.This little volume can be replaced by the saline of equal volume or saline chase agent completely, and as described below, this depends on the requirement to the hemodynamic signal quality.
In certain embodiments, the injecting systems that possesses power can be carried out the action of contrast medium isostasy then.The valve pullback operation may make vacuum bubbles be formed on back (contrast medium) side of valve.If rest on this vacuum state, these vacuum bubbles can and form actual bubble from contrast medium mixture intake-gas.By opening the valve after flexibility (elasticity) valve, for example be communicated with fluid between the contrast medium pumping installations by opening contrast bottle, partial vacuum can alleviate.Vacuum bubbles can be replaced by the contrast medium from the contrast bottle bin.After being used to make the delay of the isostatic weak point of vacuum, the valve after the flexible valves can be closed once more.In certain embodiments, the method for Figure 15 needn't comprise the action of contrast medium isostasy.
The valve pullback operation can make that also vacuum bubbles is formed in the contrast medium pumping installations.The little bubble that may be arranged in pumping installations can expand under vacuum, and is merged into bigger bubble.In contrast bottle, inject few contrast medium and can remove this air.Therefore, according to some embodiment, as shown in figure 15, carry out promotion operation to contrast bottle.The injecting systems that possesses power can make pumping installations (for example, by making the plunger in the contrast syringe advance little amount) that the air in the pumping installations is pushed in the bottle.After the delay that is used for the weak point of isostasy, any valve between contrast medium pumping installations and the bottle all can be closed.In certain embodiments, the method for Figure 15 needn't comprise the action of contrast bottle push operation.
The injecting systems that possesses power can be carried out saline chase operation then.The small diameter catheter that is filled with viscous contrast can weaken hemodynamic signal.Inject enough saline and strengthened hemodynamic signal so that the contrast medium in the conduit is replaced by saline.Therefore, saline chase agent volume can be according to the conduit size adjustment.In one embodiment, the injecting systems that possesses power can automatically be determined saline chase agent volume based on the pre-known information of conduit size.For example, can use control panel or small panel input pipe size when operator are initial, described conduit size can be used for determining saline chase agent volume by system then.Under another situation, system can determine the conduit size automatically by directly reading information from the disposable conduit pipe fitting that is using.For example, the packing of conduit pipe fitting may comprise bar code, and this bar code can use the barcode reader in the system of being installed in to read.Bar code can comprise about the various information of the disposable conduit pipe fitting that can be used by system, comprise size.In one embodiment, relevant with conduit RFID label also can be used for providing information to system.
When carrying out saline chase or contrast injection operations, system can make saline or contrast medium pumping installations with some pattern operation, for example expels or injection to carry out fluid by the pump that moves up in designated parties.When carrying out pullback operation, described system can make relevant pumping installations with other pattern operations, for example by moving pump along other direction to pull back.For example, in system 1200 or 1300, system can make contrast medium pumping installations (syringe is as shown in example) move along first direction in injection process, but the contrast medium pumping installations is moved with the feather valve of pulling back along second (for example, opposite) direction.
Method shown in Figure 15 can provide multiple benefit and advantage when carrying out by injecting systems.For example, use this system can reduce patient's danger that the conduit because of location of mistake causes.Bubble can disturb or twist just monitored heart blood power signal.These signals can be used for the injection catheter end guided safely and be placed on home in the heart by the doctor.The enforcement of method shown in Figure 15 (or similar approach) can help by in the removal system and/or be used for improving the integrity of hemodynamic signal for the bubble send fluidic disposable pipe fitting to the patient.
In conjunction with only having described the present invention as the exemplary embodiment of example and exemplary preferred embodiment and embodiment.Those skilled in the art will appreciate that under the situation that easily substantially not to break away from the scope and spirit of the present invention that claims limit any embodiment or preferred embodiment are made amendment.

Claims (31)

1. method that is used for removing air or liquid from the injecting systems that possesses power, described method comprises:
Drive first pumping installations with first operator scheme, to pass through disposable pipe fitting and a certain amount of first liquid medium of disposable valve injection;
Drive first pumping installations with second operator scheme, so that the distortion of disposable valve; And
Drive second pumping installations, with by described disposable pipe fitting and a certain amount of second liquid medium of valve injection of being deformed.
2. the method for claim 1 is characterized in that:
Driving first pumping installations with first operator scheme comprises along first direction and drives first pumping installations; And
Driving first pumping installations with second operator scheme comprises along second direction and drives first pumping installations.
3. method as claimed in claim 2 is characterized in that first direction is opposite with second direction.
4. the method for claim 1 is characterized in that, described disposable valve comprises feather valve.
5. the method for claim 1 is characterized in that:
First pumping installations comprises first syringe that wherein has plunger; And
Second pumping installations comprises second syringe that wherein has plunger.
6. injecting systems that possesses power comprises:
First pumping installations; And
Second pumping installations, wherein, described system can carry out following operation:
Drive first pumping installations with first operator scheme, to pass through disposable pipe fitting and a certain amount of first liquid medium of disposable valve injection;
Drive first pumping installations with second operator scheme, so that the distortion of disposable valve; And
Drive second pumping installations, with by described disposable pipe fitting and a certain amount of second liquid medium of valve injection of being deformed.
7. system as claimed in claim 6 is characterized in that:
First pumping installations comprises first syringe that wherein has plunger; And
Second pumping installations comprises second syringe that wherein has plunger.
8. system as claimed in claim 6 is characterized in that, described disposable valve comprises feather valve.
9. one kind is used for method that air or liquid are removed from the injecting systems that possesses power, and described method comprises:
Advance the plunger in first syringe, to pass through disposable pipe fitting and a certain amount of first liquid medium of disposable valve injection;
Withdraw plunger in first syringe is so that the distortion of disposable valve; And
In case withdrawal advances the plunger in second syringe, with by described disposable pipe fitting and a certain amount of second liquid medium of valve injection of being deformed.
10. method as claimed in claim 9 is characterized in that, first syringe is different syringes with second syringe, and first liquid medium is different liquid mediums with second liquid medium.
11. method as claimed in claim 9 is characterized in that, it also comprises:
Before the plunger in withdrawal first syringe, advance the plunger in second syringe, with second liquid medium of measuring by described disposable pipe fitting and the valve injection second that is deformed.
12. method as claimed in claim 9 is characterized in that, disposable valve comprises feather valve.
13. method as claimed in claim 12 is characterized in that, described feather valve comprises the first input end mouth that is connected to first syringe, second input port, output port and the elastomeric valve disc that is connected to second syringe.
14. method as claimed in claim 9 is characterized in that, it also comprises:
Plunger in advancing second syringe is opened first syringe momently and is provided being communicated with between the fluidic fluid reservoir to first syringe with before second liquid medium by disposable pipe fitting and the described amount of valve injection that is deformed; And
Close being communicated with between first syringe and the fluid reservoir.
15. method as claimed in claim 9 is characterized in that, it also comprises:
In case advance the interior plunger of first syringe with by first liquid medium of disposable pipe fitting, suspend a period of time with the described amount of valve injection that is deformed.
16. a fluid valve assembly comprises:
The valve keeper;
Feather valve;
Valve body;
The first input end mouth;
Second input port; And
Output port,
Wherein, the first input end mouth aligns along first axle, described first axle and valve body general tangential.
17. fluid valve assembly as claimed in claim 16 is characterized in that, first axle and valve body approximate vertical are also tangent.
18. fluid valve assembly as claimed in claim 16 is characterized in that, intravital localized area of first axle and valve or volumetric spaces general tangential.
19. fluid valve assembly as claimed in claim 16 is characterized in that:
Described valve keeper comprises the dish keeper; And
Described feather valve comprises elastomeric valve disc.
20. fluid valve assembly as claimed in claim 19 is characterized in that elastomeric valve disc comprises slot.
21. fluid valve assembly as claimed in claim 20 is characterized in that, described slot comprises angled slit.
22. fluid valve assembly as claimed in claim 16 is characterized in that, second input port is connected to the valve input port, and described valve input port is along second axial alignment, described second axis and valve body general tangential.
23. fluid valve assembly as claimed in claim 22 is characterized in that, the first axle and the second axis approximate vertical.
24. fluid valve assembly as claimed in claim 22 is characterized in that, intravital localized area of second axis and valve or volumetric spaces general tangential.
25. fluid valve assembly as claimed in claim 16 is characterized in that, second input port is connected to pressure converter.
26. fluid valve assembly as claimed in claim 16 is characterized in that:
When feather valve was in closed condition, first input end mouth and output port and second input port were isolated; And
When feather valve is in open mode, second input port and output port and isolate with the first input end mouth, when equaling or exceeding the fluid pressure that limits pressure and be applied to the first input end mouth and valve is opened, described valve is in open mode.
27. fluid valve assembly as claimed in claim 26 is characterized in that, the state of described valve disc is determined by the pressure that is applied to the first input end mouth.
28. fluid valve assembly as claimed in claim 26 is characterized in that, described qualification pressure comprises the opening pressure of valve.
29. fluid valve assembly as claimed in claim 28 is characterized in that, described opening pressure is the physical property of feather valve, the inside dimension of valve keeper, valve body and/or valve, or at least one the function in the external dimensions of valve keeper, valve body and/or valve.
30. fluid valve assembly as claimed in claim 16 is characterized in that, it also comprises the double check valve that is connected to second input port, and described double check valve is used to prevent that the pressure converter that also is connected to second input port is subjected to high pressure.
31. fluid valve assembly as claimed in claim 16 is characterized in that, it also comprises the double check valve that is connected to second input port, and described double check valve is used for to the pressure converter reflection hemodynamic signal that also is connected to second input port.
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AU2007258013A1 (en) 2007-12-21
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KR20090018645A (en) 2009-02-20
US8591477B2 (en) 2013-11-26
IL195612A (en) 2013-08-29
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US8147463B2 (en) 2012-04-03
US20100200076A1 (en) 2010-08-12
BRPI0713758A2 (en) 2012-11-06
IL195612A0 (en) 2009-09-01
CA2654090A1 (en) 2007-12-21
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CN101466421B (en) 2012-06-20
CN102512731B (en) 2014-07-16

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